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K Number
K122520
Device Name
DIGITAL THERMOMTER
Manufacturer
TaiDoc Technology Corporation
Date Cleared
2013-02-05

(172 days)

Product Code
FLLCLI
Regulation Number
880.2910
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
TD-1001 Digital Thermometer is intended to measure the body temperature orally and to be used by medical professionals in clinical and hospital environments and consumers in a home environment. It is intended for use on people of all ages.
Device Description
The Digital Thermometer TD-1001 enables easy and accurate readings over the body temperature range. It must be used in conjunction with a disposable probe cover when taking temperature. From the construction point of view, the digital thermometer comprises of a thermistor for measuring sensor, a reference resistor for comparison of temperature, a buzzer for sounding effect, an ASIC for calculating, and LCD for displaying the measuring temperature digitally for which the thermistor contacts.
More Information

K091676

Not Found

No
The device description and performance studies focus on standard digital thermometer technology and validation against established standards, with no mention of AI or ML components or training/test data sets.

No
The device measures body temperature, which is a diagnostic function, not a therapeutic one. It does not treat or cure any condition.

Yes
The device is a digital thermometer, which measures body temperature. Measurement of body temperature can aid in the diagnosis of various medical conditions, such as fever or hypothermia.

No

The device description explicitly lists hardware components such as a thermistor, reference resistor, buzzer, ASIC, and LCD, indicating it is a physical device with embedded software, not a software-only medical device.

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to provide information about a person's health. These tests are performed outside of the body (in vitro).
  • TD-1001 Function: The TD-1001 Digital Thermometer measures body temperature directly from the body (orally). It does not analyze samples taken from the body.

The description clearly states its purpose is to measure body temperature orally, which is a direct measurement from the patient, not an analysis of a sample.

N/A

Intended Use / Indications for Use

TD-1001 Digital Thermometer is intended to measure the body temperature orally and to be used by medical professionals in clinical and hospital environments and consumers in a home environment. It is intended for use on people of all ages.

Product codes (comma separated list FDA assigned to the subject device)

FLL

Device Description

The Digital Thermometer TD-1001 enables easy and accurate readings over the body temperature range. It must be used in conjunction with a disposable probe cover when taking temperature.

From the construction point of view, the digital thermometer comprises of a thermistor for measuring sensor, a reference resistor for comparison of temperature, a buzzer for sounding effect, an ASIC for calculating, and LCD for displaying the measuring temperature digitally for which the thermistor contacts.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

body (measured orally)

Indicated Patient Age Range

all ages

Intended User / Care Setting

medical professionals in clinical and hospital environments and consumers in a home environment.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

The Digital thermometer TD-1001 was validated by the tests according to ASTM E1112-00:2011 standard and met the requirements of prEN12470-3:2000 standard.

A brief description for each test was given in this section. Table 1 lists items of tests, related standard complied and format of data presentation.

ItemStandard compliedData presentationAttachment
Display temperature rangeASTM E1112-00:2011Measurement error4.1.1
Laboratory accuracyASTM E1112-00:2011Measurement error4.1.2
Operating rangeASTM E1112-00:2011Measurement error4.1.3
Storage environment testASTM E1112-00:2011Measurement error4.1.4
Shock testASTM E1112-00:2011Measurement error4.1.5
Water resistant testASTM E1112-00:2011Measurement error4.1.6
Cleaning procedure testASTM E1112-00:2011Measurement error4.1.7
Software validationISO 14971:2007Verification and validation of TD-1001 software4.2
Clinical accuracyprEN12470-3:2000Clinical bias Clinical repeatability4.3
SafetyIEC 60601-1Evaluated by SGS4.4
Electromagnetic compatibility (EMC)IEC 60601-1-2Evaluated by SGS4.5

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K091676

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

§ 880.2910 Clinical electronic thermometer.

(a)
Identification. A clinical electronic thermometer is a device used to measure the body temperature of a patient by means of a transducer coupled with an electronic signal amplification, conditioning, and display unit. The transducer may be in a detachable probe with or without a disposable cover.(b)
Classification. Class II (performance standards). The device is exempt from the premarket notification procedures in part 807, subpart E of this chapter, subject to the limitations in § 880.9 and the following conditions for exemption:(1) Device is not a clinical thermometer with telethermographic functions;
(2) Device is not a clinical thermometer with continuous temperature measurement functions; and
(3) Appropriate analysis and testing (such as that outlined in the currently FDA-recognized editions, as appropriate, of ISO 80601-2-56, “Medical electrical equipment—Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement,” or ASTM E1965, “Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature,” or ASTM E1112, “Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature,” or ASTM E1104, “Standard Specification for Clinical Thermometer Probe Covers and Sheaths”) must validate specifications and performance of the device.

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A11. 510(k) Summary

510(K) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.

K12252 The Assigned 510(k) number is:

    1. Submitter's Identification: TaiDoc Technology Corporation 3F, 5F, No.127, Wugong 2nd Rd., Wugu District, New Taipei City, 24888, Taiwan
      Correspondence: Pinjung Chen Regulatory Affairs Specialist Tel: +886-2-6625-8188 #1176 Fax: +886-2-6625-0288 Email: pinjung.chen@taidoc.com.tw

Date of submission: July 31th, 2012

    1. Device name:
      Proprietary name: Digital Thermometer, model TD-1001 Regulatory information:

  • A. Regulation section: 21 CFR 880.2910

  • Classification: Class II B.

  • C. Product Code: FLL, Clinical electronic thermometer

  • D. Panel: General Hospital (80)

    1. Intended Use:

TD-1001 Digital Thermometer is intended to measure the body temperature orally and to be used by medical professionals in clinical and hospital environments and consumers in a home environment. It is intended for use on people of all ages.

1

4. Device Description:

The Digital Thermometer TD-1001 enables easy and accurate readings over the body temperature range. It must be used in conjunction with a disposable probe cover when taking temperature.

From the construction point of view, the digital thermometer comprises of a thermistor for measuring sensor, a reference resistor for comparison of temperature, a buzzer for sounding effect, an ASIC for calculating, and LCD for displaying the measuring temperature digitally for which the thermistor contacts.

Substantial Equivalence Information:

  • A. Predicate device name:
    Omron electronic thermometer Models MC-246

  • Predicate K number: K091676 B.
    Comparison with predicate: C.

The Digital Thermometer, model TD-1001, has the following similarities to the predicate device:

  • Same intended use. D
  • Same operating principle and technological characteristics. I
  • Same measurement area (oral) D
  • Same functions and accuracy specification. D
  • 同 Same battery type.

The differences:

  • Temperature displayed range 国
  • D Operating temperature range
  • Storage temperature range
  • 门 Battery life
    1. Test Principle:

The Digital thermometer TD-1001 is the electronic thermometer operated by a thermistor as the temperature sensor and an ASIC (Application Specified IC) for

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signal processing. The basic operation principle is that a change of thermistor, caused by changes of temperature, provide signal to ASIC. ASIC gets the sensor's signal then processes the signal and calculates the result, after that displays the temperature result by a LCD.

    1. Performance Characteristics:
      The Digital thermometer TD-1001 was validated by the tests according to ASTM E1112-00:2011 standard and met the requirements of prEN12470-3:2000 standard.

A brief description for each test was given in this section. Table 1 lists items of tests, related standard complied and format of data presentation.

ItemStandard compliedData presentationAttachment
Display
temperature rangeASTM E1112-00:2011Measurement error4.1.1
Laboratory
accuracyASTM E1112-00:2011Measurement error4.1.2
Operating rangeASTM E1112-00:2011Measurement error4.1.3
Storage
environment testASTM E1112-00:2011Measurement error4.1.4
Shock testASTM E1112-00:2011Measurement error4.1.5
Water resistant testASTM E1112-00:2011Measurement error4.1.6
Cleaning procedure
testASTM E1112-00:2011Measurement error4.1.7
Software validationISO 14971:2007Verification and
validation of TD-1001
software4.2
Clinical accuracyprEN12470-3:2000Clinical bias
Clinical repeatability4.3
SafetyIEC 60601-1Evaluated by SGS4.4
Electromagnetic
compatibility
(EMC)IEC 60601-1-2Evaluated by SGS4.5

Table 1. Summary of test

3

7. Conclusion:

Based on the information provided in this submission, TD-1001 Digital thermometer is shown to be substantially equivalent to the predicate Omron electronic thermometer Models MC-246.

4

Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized emblem featuring a symbol that resembles a caduceus or a stylized representation of human services.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

February 5, 2013

Ms. Pinjung Chen Regulatory Affairs Specialist Taidoc Technology Corporation 6F, No. 127, Wugong 2nd Road Wugu District New Taipei City, Taiwan 24888

Re: K122520

Trade/Device Name: Digital Thermometer, model TD-1001 Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: January 15, 2013 Received: January 22, 2013

Dear Ms. Chen:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

5

Page 2 - Ms. Chen

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

hor

Keith
Harshfield.

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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A0. Indications for Use

Indications for Use

510(k) Number: K/22520

Device Name: Digital Thermometer, model TD-1001

Indications for Use:

.

TD-1001 Digital Thermometer is intended to measure the body temperature orally and to be used by medical professionals in clinical and hospital environments and consumers in a home environment. It is intended for use on people of all ages.

Prescription Use (21 CFR Part 801 Subpart D) And/Or Over the Counter Use __ X (21 CFR Part 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division Sign-Off Office of Device Evaluation (ODE) 510(k)_k122520

Page 1 of

Sajjad H. Syed
Digitally signed by Sajjad H. Syed
DN: c=US, o=U.S. Government, ou=HHS,
ou=FDA, ou=People, cn=Sajjad H. Syed
0.9.2342.19200300.100.1.1=2000601742
Date: 2013.02.05 11:08:03 -05'00'

n Sign-Off)
of Anesthestology, General Hospital
of Anesthestology, General Devices on of Anestholorological

510(k) Number: K122520

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